Active not recruitingOBSERVATIONAL

Evidence For Fusion In Spine With Orthoss®

This research is investigating how well a special bone graft material, called Orthoss®, performs during certain back operations. If you need surgery for conditions like 'slipped disc' (spondylolisthesis), narrowing of the spine (spinal stenosis), or wear and tear of the discs, your surgeon might use a bone graft to help your spine become stable. This study observes patients who receive Orthoss® mixed with some of their own bone during surgery. The main goal is to check how effectively this mixture helps the bones grow together (a process called 'fusion') and to ensure it is safe. Researchers will follow patients for a period after their operation to see the long-term results of using Orthoss® for spinal stability.

At a glance

Status

Active not recruiting

Sponsor

Geistlich Pharma AG

Enrolment target

Start

18 Jan 2019

Estimated completion

01 Jan 2027

Lumbar Spondylolisthesis Involving L4-L5 Lumbar Spondylolisthesis Involving L5-S1 Lumbar Spinal Stenosis Lumbar Disc Degeneration

What is this study about?

This study is about a type of back surgery called 'spinal fusion.' Spinal fusion is an operation where a surgeon joins two or more bones in your spine together so they can heal into one solid bone. This helps to make your spine more stable and can reduce pain caused by conditions like a 'slipped disc' (spondylolisthesis), where one spinal bone moves out of place, or 'spinal stenosis,' which is a narrowing of the spinal canal that can press on nerves.

During spinal fusion, surgeons often use bone grafting material to help the bones fuse together. This study is looking specifically at a material called Orthoss®. It wants to see how well Orthoss®, when mixed with a small amount of your own bone, helps the fusion process. Orthoss® is already approved for use in this type of surgery.

This is an 'observational study,' which means the doctors will simply observe patients who are having spinal fusion surgery as part of their normal treatment. They won't ask you to do anything different from what you would normally do for this surgery. The main aim is to gather information on how effective Orthoss® is in helping the spine fuse and to make sure it's safe for patients. This information will help doctors understand more about the best ways to help people with back problems.

Key takeaways

This study evaluates Orthoss® bone graft material in spinal fusion surgery.
It aims to check how well Orthoss® helps bones fuse and if it's safe.
Participation means your usual spinal fusion surgery and follow-up will be observed.
The study focuses on common lower back conditions like 'slipped disc' or spinal narrowing.
It's an observational study, meaning no special treatments or procedures are involved for you.
Orthoss® is already an approved material for this type of surgery.

Who may be eligible?

To take part in this study, you must be at least 18 years old. You also need to be planning to have spinal fusion surgery for specific back problems that affect certain levels of your lower back (L4-L5 and/or L5-S1). These conditions include degenerative disc disease (wear and tear of the spinal discs), certain types of slipped disc (spondylolisthesis), or narrowing of the spine (spinal stenosis). You must be able to attend all follow-up appointments and understand what the surgery involves, providing your written consent.

There are several reasons why you might not be able to join. For example, if you have general medical conditions that make surgery unsafe, or if you've had cancer treatment (like radiotherapy or chemotherapy) in the last five years. You also can't take part if you are pregnant, breastfeeding, or a woman of childbearing age not using effective birth control. Other reasons include having an infection where the surgery will be, a known allergy to bone material from cows (bovine), a history of alcohol or drug abuse in the past year, or if you're taking certain strong medications like high-dose steroids.

Finally, you can't be in this study if you are currently participating in another clinical study, or have done so in the last six months. The researchers also won't include anyone considered 'vulnerable,' meaning people who might not be able to make their own decisions easily.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having spinal fusion surgery for a 'slipped disc', spinal narrowing, or disc wear and tear in your lower back (L4-L5 or L5-S1)?
Are you able to attend all planned follow-up appointments after your surgery?
Are you *not* currently pregnant or breastfeeding?
Have you *not* had cancer treatment (like chemo or radiotherapy) in the last five years?
Are you *not* currently in another clinical research study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be asked to do anything extra or different from what you would normally do for your spinal fusion surgery. The study simply observes how you recover and how well your spine fuses after your standard operation, where Orthoss® is used as part of the bone graft. This means you’ll have your planned surgery and then attend your usual follow-up appointments with your surgeon. The doctors will collect information from your medical records and appointments to see how your spine is healing. The total duration of your participation will depend on the normal follow-up schedule your surgeon sets for spinal fusion patients, typically involving appointments over several months to check on your recovery and fusion progress.

Potential risks and benefits

The potential benefit of participating is that the study might provide more detailed information about how well Orthoss® works in spinal fusion, helping to improve care for future patients. For you, the risks are generally the same as those associated with any spinal fusion surgery, such as infection, bleeding, or nerve damage, as the intervention itself (using Orthoss®) is part of standard care. You always have the right to withdraw from the study at any time without affecting your medical care, and your decision will not be held against you.

Locations (3)

Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
Verified postcode
Augsburg, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
Klinikum Magdeburg gGmbH
Verified postcode
Magdeburg, Germany

Common questions

What is spinal fusion surgery?

Spinal fusion is an operation to join two or more bones in your spine together so they can heal into one strong, stable bone.

What is Orthoss®?

Orthoss® is a special material used to help new bone grow and fuse during spinal surgery. It's often mixed with a small amount of your own bone.

Will I get special treatment if I join this study?

No, you will receive the same standard care and surgery that you would normally get for your condition. The study simply observes the results.

Is Orthoss® already approved for use?

Yes, Orthoss® is already approved for use in this type of surgery within the European Union.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your medical care in any way.